NSF International Publishes National Standard for Excipient Good Manufacturing Practices

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NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

Global public health organization NSF International has published the first American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients, NSF announced on Mar. 11, 2015. The new standard and auditing program assists pharmaceutical companies in verifying regulatory compliance and strengthening safety and quality throughout the excipient supply chain.

The globalization of the pharmaceutical industry combined with a global regulatory focus on preventing counterfeits and adulterated products has created a need for a comprehensive excipient quality and control standard, NSF said in the press release. For example, the FDA Safety and Innovation Act (FDASIA) requires US manufacturers to verify and document that the raw materials used in finished products are also meeting appropriate GMPs. The NSF/IPEC/ANSI 363 standard for pharmaceutical excipient GMPs provides a harmonized and comprehensive set of criteria for the quality management systems used in the manufacture of pharmaceutical excipients worldwide.

The NSF/IPEC/ANSI 363 standard was developed in partnership with the International Pharmaceutical Excipients Council (IPEC) with balanced input from a committee of pharmaceutical excipient experts from regulatory, industry, and academic fields. The standard references 14 regulatory guidelines and industry standards for excipients, including FDA regulations, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and IPEC and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.

"Through developing NSF/IPEC/ANSI 363 and its corollary certification program, NSF International is providing a means for excipient suppliers to demonstrate to pharmaceutical manufacturers that they meet the necessary GMP requirements, while also assisting regulators and regulated companies with ensuring the quality of the global pharmaceutical supply chain," said Maxine Fritz, executive vice-president Pharma Biotech, NSF Health Sciences, a division of NSF International, in the press release.


"Excipient manufacturers certified to the NSF/IPEC/ANSI 363 standard demonstrate that their excipients are manufactured to the appropriate GMPs for pharmaceutical use, which in most cases results in fewer customer audits. Both regulators and industry benefit from the time and cost savings of a harmonized excipient GMP standard like NSF/IPEC/ANSI 363," said John Giannone, chairman, IPEC-Americas, in the press release.

Source: NSF